Medical cannabis lozenges  and compositions thereof

ABSTRACT

A method for optimizing the therapeutic effects provided by CBD on the one hand, and the psychotropic effects provided by THC on the other hand, in a sublingual medicament, the method includes the steps of obtaining a concentrated extract of  cannabis  in which the concentration of CBD is known and the concentration of THC is known, formulating a hydrophilic mixture containing ingredients such as sugar, corn syrup, xylitol, purified water, organic flavorings, coconut oil, and concentrated extract of  cannabis , wherein the amount of CBD is as high as possible and where the amount of THC is precisely controlled, forming lozenges, and administering the medicament.

RELATED APPLICATIONS

None.

FIELD OF THE INVENTION

This invention relates to a variety of medical cannabis lozenges andhard candies, and more particularly, to lozenges and hard candies thatcontain different controlled levels of cannabidiol andtetrahydrocannabinol.

BACKGROUND OF THE INVENTION

A psychoactive drug, psychopharmaceutical, or psychotropic is a chemicalsubstance that crosses the blood-brain barrier and acts primarily uponthe central nervous system where it affects brain function, resulting inalterations in perception, mood, consciousness, cognition, andbehavior.[1] These substances may be used recreationally, topurposefully alter one's consciousness, or as entheogens, for ritual,spiritual, and/or shamanic purposes, as a tool for studying oraugmenting the mind. Many psychoactive drugs have therapeutic utility,e.g., as anesthetics, analgesics, or for the treatment of psychiatricdisorders.

Psychoactive substances often bring about subjective changes inconsciousness and mood that the user may find pleasant (e.g. euphoria)or advantageous (e.g. increased alertness) and are thus reinforcing.Thus, many psychoactive substances are abused, that is, usedexcessively, despite health risks or negative consequences. Withsustained use of some substances, psychological and physical dependence(“addiction”) may develop, making the cycle of abuse even more difficultto interrupt. Drug rehabilitation aims to break this cycle ofdependency, through a combination of psychotherapy, support groups,maintenance and even other psychoactive substances. However, the reverseis also true in some cases, that certain experiences on drugs may be sounfriendly and uncomforting that the user may never want to try thesubstance again. This is especially true of the deliriants (e.g. Jimsonweed) and powerful dissociatives (e.g. Salvia divinorum). Most purelypsychedelic drugs are considered to be non-addictive (e.g. LSD,psilocybin, mescaline). “Psychedelic amphetamines” orempathogen-entactogens (such as MDA and MDMA) may produce an additionalstimulant and/or euphoriant effect, and thus have an addictionpotential.

Medical cannabis has several potential beneficial effects. Medicalmarijuana is helpful to people who experience chronic non-cancer pain,vomiting and nausea caused by chemotherapy. The drug can also help withtreating symptoms of AIDS patients. As of 2today, the use of medicalmarijuana is legalized in over 20 U.S. states, and legalization ofmarijuana for any purpose by individuals over the age of 18 ha beenapproved in 2 different states. Animal studies show cannabinoids foundin marijuana may have analgesic and anti-inflammatory effects, antitumoreffects, and anticancer effects, including the treatment of breast andlung cancer.

Medical cannabis (or medical marijuana) refers to the use of cannabisand its constituent cannabinoids, such as Cannabidiol (“CBD”), asmedical therapy to treat disease or alleviate symptoms. Cannabis hasbeen used to reduce nausea and vomiting in chemotherapy and people withAIDS, and to treat pain and muscle spasticity.

Medical cannabis can be administered by a variety of routes, includingvaporizing or smoking dried bud and leaf portions, eating leaf orextracts, and taking capsules. Synthetic cannabinoids are available asprescription drugs in some countries. Medical cannabis can also be madeinto an edible form such as lozenges, candies, baked goods.

Tetrahydrocannabinol THC, is the principal psychoactive constituent ofthe cannabis plant. An aromatic terpenoid, THC has a very low solubilityin water, but good solubility in most organic solvents, specificallylipids and alcohols. In general, THC has mild to moderate analgesiceffects, and cannabis can be used to treat pain by altering transmitterrelease on dorsal root ganglion of the spinal cord and in theperiaqueductal gray. Other effects include relaxation, alteration ofvisual, auditory, and olfactory senses, fatigue, and appetitestimulation. THC has marked antiemetic properties, and may also reduceaggression in certain subjects. Evidence suggests that THC helpsalleviate symptoms suffered both by AIDS patients, and by cancerpatients undergoing chemotherapy, by increasing appetite and decreasingnausea. It has also been shown to assist some glaucoma patients byreducing pressure within the eye, and is used in the form of cannabis bya number of multiple sclerosis patients, who use it to alleviateneuropathic pain and spasticity.

Cannabidiol (“CBD”) is one of at least 85 cannabinoids found incannabis. It is a major constituent of the plant, second to THC, andrepresents up to 40% in its extracts. Compared with THC, CBD is notpsychoactive in healthy individuals, and is considered to have a widerscope of medical applications than THC, including to epilepsy, multiplesclerosis spasms, anxiety disorders, bipolar disorder, schizophrenia,nausea, convulsion and inflammation, as well as inhibiting cancer cellgrowth.

Cannabis growers have been developing different strains of cannabisplants that have different THC and CBD levels. Medical cannabis usershave been demanding medical cannabis products that have CBD as the mainactive ingredient, and little or no THC, providing some of the medicinalbenefits of cannabis without the psychoactive effects caused mainly byTHC.

U.S. Patent Publication No. 20020136752 by Whittle et al., dated Sep.226, 2002, is directed to pharmaceutical formulations for use in theadministration of medicaments, in particular lipophilic medicaments, viamucosal surfaces. Paragraph 27 states: “Both sublingual and buccalformulations depend on the efficient transfer of medicament from ahydrophilic vehicle to the mucous membrane of the sublingual or buccalmucosae. Transfer of medicament through the interstices between orthrough epithelial cells is governed principally by the lipid solubilityof the medicament. Where a drug is water insoluble this is a furtherbarrier to absorption from the sublingual area. There are thereforephysical and biological limitations on the therapeutic usefulness oflipophilic medicaments such as, for example, cannabis and cannabinoidsgiven by mouth and swallowed.”

ADVANTAGES AND SUMMARY OF THE INVENTION

The present invention relates to medical cannabis lozenges that are madefrom concentrated cannabis oil. The medical cannabis lozenges of thepresent invention are both sublingual and digestive and have a high CBDlevel and a wide range of THC levels. Providing users an option todecide the level of acceptable psychoactive effects caused mainly byTHC, while getting the medical benefits of CBD. Applicant submits thereare no such products currently available.

The present invention relates to orally administered medical cannabisdelivery product that has a high CBD content for medical purposes and acontrolled level of THC.

One object and advantage of the present invention is to provide a moresocially acceptable, easier and more convenient way for delivery ofmedical cannabis.

Another object and advantage of the present invention is to provide amore taste oriented option for edible medical cannabis products comparedto oils or extracts.

Yet another object and advantage of the present invention is to providea way to fully capitalize on the medical benefits of CBD in medicalcannabis products.

Yet another object and advantage of the present invention is toeliminate or minimize the psychoactive effects of THC in medicalcannabis products, or otherwise control the level of THC in amedicament.

Yet another object and advantage of the present invention is to allowusers easily control the dosage of medical cannabis products bysplitting the tablets.

Yet another object and advantage of the present invention is to providea way for users to control the THC intake and its associated effects.

Yet another object and advantage of the present invention is to providea way to select medical cannabis products made from sativa strains,indica strains or combination thereof.

Yet another object and advantage of the present invention is to providea formulation and delivery method that overcomes physical and biologicallimitations on the therapeutic usefulness of lipophilic medicaments suchas, for example, cannabis and cannabinoids given by mouth and swallowed.

Yet another object and advantage of the present invention is to providesublingual and buccal formulations that depend on the efficient transferof medicament from a hydrophilic vehicle to the mucous membrane of thesublingual or buccal mucosae.

Further details, objects and advantages of the present invention willbecome apparent through the following descriptions, and will be includedand incorporated herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is the chemical structure of Tetrahydrocannabinol (“THC”).

FIG. 2 is the chemical structure of Cannabidiol (“CBD”).

FIGS. 3 and 4 are representative views of samples 200 and 400 of medicalcannabis lozenges 100 of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The description that follows is presented to enable one skilled in theart to make and use the present invention, and is provided in thecontext of a particular application and its requirements. Variousmodifications to the disclosed embodiments will be apparent to thoseskilled in the art, and the general principals discussed below may beapplied to other embodiments and applications without departing from thescope and spirit of the invention. Therefore, the invention is notintended to be limited to the embodiments disclosed, but the inventionis to be given the largest possible scope which is consistent with theprincipals and features described herein.

It will be understood that in the event parts of different embodimentshave similar functions or uses, they may have been given similar oridentical reference numerals and descriptions. It will be understoodthat such duplication of reference numerals is intended solely forefficiency and ease of understanding the present invention, and are notto be construed as limiting in any way, or as implying that the variousembodiments themselves are identical.

As best shown in FIG. 3, in one embodiment, medical cannabis lozenges100 of the present invention take shape and form of conventional lozengetablet or hard candy or crumble. In the lozenges format as best shown inFIG. 3, users can split individual tablet(s) 102 from the bar 104,according to the dosage desired. In alternative embodiments, medicalcannabis lozenges 100′ [not shown] can be made into a candy format suchas an individual drop 402 as best shown in FIG. 4, a lollipop or evencrumble. Regardless of formats, medical cannabis lozenges 100 areadministered orally. Users can leave medical cannabis lozenges 100 intheir mouth and let it dissolve naturally or ingest it, or combinationthereof. Active ingredients of medical cannabis lozenges 100 areabsorbed to users' body by sublingual administration and digestivetracts. Medical cannabis lozenges bar 104, as best shown in FIG. 3, arepackaged in air-tight pouches 200 and distributed in compliance withU.S. National Food Safety standards.

Efficiency of delivery of active ingredients are enhanced by the size,shape, solubility and hardness of medical cannabis lozenges 100. In oneembodiment, ideally medical cannabis lozenges tablets 102 should be madein regular lozenge size for ease of consumption.

In one embodiment, the most important active ingredient of medicalcannabis lozenges 100 is Cannabidiol (“CBD”), and followed byTetrahydrocannabinol (“THC”). CBD, chemical structure shown in FIG. 2,is a non psychoactive compound found in cannabis plants. While THC,chemical structure shown in FIG. 1, is the only psychoactive compoundfound in cannabis plants. CBD is not intoxicating and indeed it has beenpostulated that the presence of CBD in cannabis may alleviate some ofthe potentially unwanted side-effects of THC. The main focus of thepresent invention 100 is to capitalize on the medical applications ofCBD by having a relatively high level, and a controlled level of THCaccording to users' preference of psychoactive effects of THC.

In one embodiment, THC delivery is not the main focus of medicalcannabis lozenges 100 of the present invention. The purpose of medicalcannabis lozenges 100 is to deliver the highest level of CBD possibleand then allow users to determine how much THC is needed or desired tomost effectively address their personal health needs.

In one embodiment, medical cannabis lozenges 100 have two activeingredients, viz., CBD and THC. The source of CBD and THC is theconcentrated cannabis oil, which contribute solely to the CBD and THCcontent. In addition, a selective combination of the following inactiveingredients including cane sugar, syrup, filtered water, natural organicflavoring, Xylitol (all natural, U.S. manufactured from birch), coconutoil (raw, organic), natural organic colorings, which contribute to thevolume/weight, shape, color, taste, texture, hardness and solubility ofmedical cannabis lozenges 100.

Concentrated Cannabis Oil:

Concentrated cannabis oil is apparently made from cannabis plants. Eachcannabis strain has a particular Cannabinoids (including CBD and THC)profile. The concentrated cannabis oil used in the medical cannabislozenges 100 of the present invention comes in two forms, viz. Base offood grade hexane and base of food grade ethanol. Depending on thecombination of cannabis strains that the concentrated cannabis oil ismade from, each batch of concentrated cannabis oil has a different CBDvs. THC ratio, which will be used for different variants of the presentinvention 100. Besides the CBD and THC content, concentrated cannabisoil used in the present invention 100 also takes into account theperceived psychoactive effects of the species of cannabis plants used,particularly cannabis sativa (“sativa”) and cannabis indica (“indica”)which are both annual herbaceous plants in the Cannabis genus. Theperceived effects of sativa are well known for its cerebral high, henceused daytime as medical cannabis, while indica is perceived for itssedative effects which some prefer for night time use. Indica plants arenormally shorter and stockier plants than sativa plants. They have wide,deeply serrated leaves and a compact and dense flower cluster. Theeffects of indica are predominantly physical and sedative. Due to therelaxing nature of indica, they are best used for non-active times ofthe day and before bed. A careful and skillful selection process ofcannabis strains is conducted to ensure concentrated cannabis oilyielded has a particular CBD:THC ratio range and a desirable sativa andindica proportion.

Each batch of concentrated cannabis oil yielded will then be sent to alaboratory which its CBD and THC level will be tested using the liquidchromatography method. Liquid chromatography-mass spectrometry (LC-MS,or alternatively HPLC-MS) is an analytical chemistry technique thatcombines the physical separation capabilities of liquid chromatography(or HPLC) with the mass analysis capabilities of mass spectrometry (MS).Results of the LC-MS test will indicate CBD and THC content by weight ineach batch of concentrated cannabis oil. Moreover each batch ofconcentrated cannabis oil will go through the phenol analysis todetermine the phenol level. Since CBD and THC cannot be extractedindividually from concentrated cannabis oil, sometimes mixing of variousbatches of concentrated cannabis oil is required to achieve a mixturethat has the desirable CBD:THC ratio and sativa vs. indica proportion.However, in the future it is anticipated that separation of the CBD fromthe THC will also be possible, and then blending of THC and CBD toattain the optimum ration of CBD to THC can be achieved somewhat moreefficiently but with the same result.

In one embodiment, medical cannabis lozenges 100 is to deliver at leastthree levels of CBD:THC ratios. In all three variants, the purpose is toachieve as a high CBD content as possible to gain the maximum medicalbenefits from CBD, and maintain a threshold which is a minimum of 25 mgper one unit of medical cannabis lozenges 100. Due to the fact that CBDcannot be extracted from the concentrated cannabis oil and addedindividually, there is a natural limit of how much CBD can be present inthe present invention 100.

(One unit of medical cannabis lozenges 100 equals to 2 g to 4 g dryweight of cannabis, and the absolute weight of one unit is in theapproximate range of 2 g to 15 g.)

1. The first variant, out of one unit of medical cannabis lozenges 100,it would have a maximum of 0-10 mg of THC and a minimum of 25 mg of CBD.Therefore, THC vs. CBD ratio by weight ranges from 0 to 0.40. The firstvariant is considered to have little to no psycho-activity. It is alsobelieved with time and also been shown by some researches that smalltraces of THC although slightly psychoactive will be countered by thepresence of high CBD content, especially in ratios of 1 mg THC to 7-10mg or higher of CBD.

2. The second variant would be moderately psychoactive. Out of one unitof medical cannabis lozenges 100, a maximum of 10-40 mg of THC to aminimum of 25 mg of CBD. The THC vs. CBD ratio by weight in this variantranges from 0 to 1.60. In this variant, a high sativa proportionconcentrated cannabis oil is used. Hence, the psychoactive effects willbe light and in many cases uplifting as the THC profile will be morereflective of the effects of the sativa variety of the cannabis plant.Sativa are generally viewed by medicine as being uplifting and antidepressant in nature, a day time use medicine.

3. The third variant would also be moderately psychoactive and hassimilar THC:CBD ratio of the second variant. Out of one unit of medicalcannabis lozenges 100, a maximum of 10-40 mg of THC to a minimum of 25mg of CBD. The THC vs. CBD ratio by weight in this variant also rangesfrom 0 to 1.60. The difference in the third variant is that a mix ofindica and sativa proportion concentrated cannabis oil is used. Thesevariant of medical cannabis lozenges 100 will be both moderatelypsychoactive mainly due to the elevated THC level (10-40 mg per oneunit), while also offering increased medicinal relief from pain,inflamation, etc mainly from the high CBD level (25 mg+ per one unit).In this variant, there will be offerings of both sativa and indica whichis more suitable for night time usage. Sativa as earlier described foruse for treatment of depression, anxiety and low energy. Indica is morecommonly used for pain, sleep issues and creating appetite. Althoughcurrent researches indicate the THC compound is exactly the same in bothsativa and indica strains, the difference in their perceivedpsychoactive and physiological effects distinguishes variant 2 and 3.

Manufacturing Process:

(Measurement based on making one unit of medical cannabis lozenges 100)

Firstly, the sole active ingredient concentrated cannabis oil with aparticular THC:CBD ratio and sativa vs. indica proportion is selected.If the desirable THC:CBD ratio concentrated cannabis oil is notavailable, a few concentrated cannabis oils of different THC:CBD ratiois mixed to attain the desirable level. Concentrated cannabis oil ormixture will be weight to ensure that a minium of 25 mg CBD will bepresent in the final product. Secondly, inactive ingredients will beadded to fill out the final weight and achieve a desirable non-medicalproperties such as taste, color, viscosity, hardness, etc. of medicalcannabis lozenges 100. For example, sugar, corn syrup is added for tasteand texture. Organic flavorings and colorings are added for taste andcolor. In some variants of medical cannabis lozenges 100, unpressedvirgin organic coconut oil, non GMO Xylitol will be added for otherpurposes. The mixture will be heated and stirred until all ingredientsare well mixed. It will then be poured into a mold and let set.

Sample Products:

As shown in FIG. 3, CBDOOS™ is one of the branded medical cannabislozenges 200 available in the market now. It is made to achieve a gem or“see through” hard candy lozenge quality, appearance and texture. Theformula for making 50 units consists of 2.25 cups of sugar, ⅔ cup ofcorn syrup, ¾ cup of purified water, 1 g of organic flavorings and labdetermined proprietary amount of concentrated cannabis oil. In oneembodiment, approximately 2.5 grams of cannabis oil will result in aproduct containing approximately 25 mg of CBDs per unit.

As shown in FIG. 4, GOOD-EZ™ is another branded medical cannabislozenges 400 of the present invention available in the market now. It ismade to be a sugar free xylitol based lozenge or crumble and arefinished in a rose petal top 402, using 2.25 cups of USA sourced Birchnon GMO Xylitol, ¼ cup of unpressed virgin organic coconut oil, 1 dramof organic flavorings and lab determined proprietary amount ofconcentrated cannabis oil. In one embodiment, approximately 2.5 grams ofcannabis oil will result in a product containing approximately 25 mg ofCBDs per unit.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the present invention belongs. Although any methods andmaterials similar or equivalent to those described can be used in thepractice or testing of the present invention, the preferred methods andmaterials are now described. All publications and patent documentsreferenced in the present invention are incorporated herein byreference.

While the principles of the invention have been made clear inillustrative embodiments, there will be immediately obvious to thoseskilled in the art many modifications of structure, arrangement,proportions, the elements, materials, and components used in thepractice of the invention, and otherwise, which are particularly adaptedto specific environments and operative requirements without departingfrom those principles. The appended claims are intended to cover andembrace any and all such modifications, with the limits only of the truepurview, spirit and scope of the invention.

I claim:
 1. A lozenge consisting essentially of hexane-extractedcannabis sativa oil, hexane-extracted cannabis indica oil, and xylitol.2. The lozenge of claim 1 having a mass of between 2 grams and 15 grams.3. The lozenge of claim 2 containing a minimum of 25 mg of CBD.
 4. Thelozenge of claim 2 containing a maximum of 40 mg of THC.
 5. The lozengeof claim 1 further consisting essentially of an ingredient selected fromthe group consisting of sugar, corn syrup, flavorings, coloring agents,coconut oil, purified water and mixtures thereof.
 6. A method forminimizing the psychoactive effects of THC in a human which isadministered a sublingual lozenge, the method consisting essentially of:a) formulating the lozenge of claim 1; and b) administering the lozengeof claim 1 sublingually to a human until the lozenge is dissolved in thehuman.
 7. The method of claim 6, wherein the step of formulating thelozenge is maximizing the CBD concentration.
 8. The method of claim 6,wherein the step of formulating the lozenge is minimizing the THCconcentration.
 9. The method of claim 6, wherein the step of formulatingthe lozenge is maximizing the THC concentration.